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Trial record 36 of 143 for:    NIFEDIPINE

REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial (REVERENT)

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ClinicalTrials.gov Identifier: NCT02499822
Recruitment Status : Recruiting
First Posted : July 16, 2015
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Brief Summary:

The purpose of this study is

  1. to compare the effects of nifedipine GITS and ramipril on blood pressure variability in subjects with elevated blood pressure variability.
  2. to assess whether the degree of treatment-induced changes in blood pressure variability, is related to the degree of regression (or progression) of organ damage in heart, kidneys and carotid arteries.

Condition or disease Intervention/treatment Phase
Hypertension High Blood Pressure Variability Drug: Nifedipine GITS Drug: Ramipril Phase 4

Detailed Description:
Elevated blood pressure variability (BPV) is associated with adverse cardiovascular outcomes and organ damage in hypertensive subjects. An antihypertensive treatment able to reduce BPV independently of BP lowering effect might thus provide additional protection in terms of cardiovascular risk in subjects with elevated BPV, independently on its effect of BP itself. However, data on the effects of different classes of antihypertensive drugs on BPV are limited and inconsistent. Some studies have suggested a possible usefulness of calcium antagonists in this setting. Based on the above considerations the investigators hypothesize that a calcium channel blocker nifedipine GITS, will provide a greater BPV lowering effect, when compared with ramipril, independently from the reduction in mean BP level. Based on the above considerations, the primary objective of this study is to compare the effects of nifedipine GITS and ramipril on different estimates of BPV (24 h BPV, home BPV, and visit-to-visit BPV) in subjects with elevated BPV. The secondary objective is to assess whether the degree of treatment-induced changes in BPV, is related to the degree of regression (or progression) of organ damage, after accounting for mean BP reduction by treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short - Medium and Long Term Blood Pressure Variability in Essential Hypertensive Patients Treated With Nifedipine GITS or Ramipril - a Randomized Trial
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nifedipine GITS 30 mg slow release
Nifedipine GITS 30 mg slow release in tablets.
Drug: Nifedipine GITS
Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.

Experimental: Ramipril 10 mg
Ramipril 10 mg in tablets.
Drug: Ramipril
Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.




Primary Outcome Measures :
  1. Variability (standard deviation) of home systolic blood pressure at final visit [ Time Frame: After 10 weeks of study treatment ]

Secondary Outcome Measures :
  1. Variability (standard deviation) of home diastolic blood pressure measured at final visit [ Time Frame: At baseline and after 10 weeks of study treatment ]
  2. Short term 24h variability of systolic blood pressure at final visit (24h weighted standard deviation) [ Time Frame: At baseline and after 10 weeks of study treatment ]
  3. Short term 24h variability of diastolic blood pressure at final visit (24h weighted standard deviation) [ Time Frame: At baseline and after 10 weeks of study treatment ]
  4. Visit-to-visit variability (standard deviation) of systolic blood pressure assessed over the three last visits [ Time Frame: At baseline and after 6, 8 and 10 weeks of study treatment ]
  5. Visit-to-visit variability (standard deviation) of diastolic blood pressure assessed over the three last visits [ Time Frame: At baseline and after 6, 8 and 10 weeks of study treatment ]
  6. Mean 24 hour systolic blood pressure at final visit [ Time Frame: At baseline and after 10 weeks of study treatment ]
  7. Mean 24 hour diastolic blood pressure at final visit [ Time Frame: At baseline and after 10 weeks of study treatment ]
  8. Sokolow index at the end of the extension study [ Time Frame: At baseline and after 12 months of study treatment ]
  9. Cornell voltage duration index at the end of the extension study [ Time Frame: At baseline and after 12 months of study treatment ]
  10. Left ventricular mass index at the end of the extension study [ Time Frame: At baseline and after 12 months of study treatment ]
  11. Microalbuminuria (albumin-creatinine ratio) at the end of the extension study [ Time Frame: At baseline and after 12 months of study treatment ]
  12. Estimated glomerular filtration rate (eGFR, by CKD-EPI formula) at the end of the extension study [ Time Frame: At baseline and after 12 months of study treatment ]
  13. Carotid-femoral pulse wave velocity (cfPWV) at the end of the extension study [ Time Frame: At baseline and after 12 months of study treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects
  • Age 35-75 years
  • Clinic systolic BP ≥140 mmHg and/or diastolic BP ≥ 90 mmHg (under no antihypertensive treatment)
  • Daytime BP on ambulatory BP monitoring (ABPM) ≥135 mmHg systolic and/or ≥85 mmHg diastolic (under no antihypertensive treatment)
  • Home SBP standard deviation (SD) >7 mmHg and/or daytime ambulatory SBP SD >12 mmHg
  • Patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks' washout period
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Subjects treated with ≥ 2 antihypertensive drugs (except those on two drugs in low doses)
  • Treated subjects with on-treatment clinic BP ≥160 mmHg systolic and/or 100 mmHg diastolic
  • Treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
  • Contraindications to study treatments as detailed in the relative Summaries of Medical Product Characteristics for ramipril (hypersensitivity to ramipril or any of the excipients or any other ACE inhibitor, history of angioneurotic oedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, second and third trimesters of pregnancy, lactation, haemodynamically relevant renal artery stenosis, hypotensive or haemodynamically unstable patients) or nifedipine GITS (known hypersensitivity to nifedipine or to any of the excipients, pregnancy before week 20 and during breastfeeding, cardiovascular shock, concomitant treatment with rifampicin, patients with a Kock pouch)
  • Cardiovascular diseases other than hypertension (coronary heart disease, heart failure or left ventricular systolic dysfunction of any degree, atrial fibrillation or frequent arrhythmias, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
  • Chronic kidney disease
  • Suspected or confirmed secondary hypertension
  • Diabetes mellitus
  • Subjects with conditions other than those mentioned above, where compelling indications for the use of any specific class of antihypertensive medication exist, according to current (e.g. European Society of Cardiology) guidelines
  • Other conditions deemed relevant by the investigator (including respiratory disorders, liver disease, renal disease, thyroid disorders)
  • BMI ≥35 kg/m2
  • Known severe obstructive sleep apnea (apnea-hypopnea index > 30 or use of CPAP)
  • Premenopausal women not using effective contraceptive methods
  • Elevated probability of noncompliance with the study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499822


Contacts
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Contact: Gianfranco Parati, MD 390261911 ext 2890 gianfranco.parati@unimib.it
Contact: Grzegorz Bilo, MD 390261911 ext 2903 g.bilo@auxologico.it

Locations
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China
Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital Shanghai Institute of Hypertension, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China
Contact: Jiguang Wang, MD       jiguangwang@aim.com   
Greece
Hypertension Center, Third University Department of Medicine, Sotiria Hospital Not yet recruiting
Athens, Greece
Contact: George S Stergiou, MD       gstergi@med.uoa.gr   
Italy
Istituto Auxologico Italiano Recruiting
Milan, Italy
Contact: Gianfranco Parati, MD    390261911 ext 2890    gianfranco.parati@unimib.it   
Sponsors and Collaborators
Istituto Auxologico Italiano
Bayer
Investigators
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Principal Investigator: Gianfranco Parati, MD Istituto Auxologico Italiano - Milan, Italy

Publications:

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Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT02499822     History of Changes
Other Study ID Numbers: 09F401
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: March 2018
Keywords provided by Istituto Auxologico Italiano:
Hypertension
Blood pressure variability
Home systolic blood pressure
Organ damage
Nifedipine GITS
Ramipril
Additional relevant MeSH terms:
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Nifedipine
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents