Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure (CLONCAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT01761916
First received: October 30, 2012
Last updated: July 25, 2013
Last verified: June 2013
  Purpose

The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.

Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.

The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.

Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.

There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.

The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.


Condition Intervention Phase
Preeclampsia
Drug: CLONIDINE
Drug: CAPTOPRIL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for Effectiveness of Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • Time until resolution of very high blood pressure episode [ Time Frame: During hospital stay, up until one month postpartum ] [ Designated as safety issue: No ]
    The time until resolution of very high blood pressure episode after clonidin or captopril use.


Secondary Outcome Measures:
  • Maternal outcomes [ Time Frame: During hospital stay, up until one month postpartum ] [ Designated as safety issue: No ]
    Daily average systolic blood pressure;Daily average diastolic blood pressure;Need for combination with other hypotensive agent for the peak pressure or antihypertensive treatment maintenance;Need for new dose of antihypertensive medication for very high blood pressure; Laboratory tests during the postpartum; Adverse effects of hypotensive used for very high blood pressure;Puerperal complications


Enrollment: 90
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLONIDINE
Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg)
Drug: CLONIDINE
Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg)
Other Name: CLON
Active Comparator: CAPTOPRIL
Postpartum patients with very high blood pressure will be treated with oral CAPTOPRIL (25mg)
Drug: CAPTOPRIL
Postpartum patients with very high blood pressure will be treated with oral captopril (25mg)
Other Name: CAP

Detailed Description:

The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.

Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.

The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.

Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.

There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.

The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.

A triple blind randomized clinical trial will be conducted. Postpartum women with hypertensive disorders of pregnancy, admitted to the obstetric ICU of IMIP will be included in the research. After inclusion in the study, drugs for for very high blood pressure, according to randomization(captopril and clonidine)will be used. clonidine and captopril are administered at a dose of 25mg and 0.1mg respectively. If there is no control of blood pressure in 20 minutes new hypotensive doses will be administered until a total of 150mg/day (six tablets) and Captopril 0.6 mg / day (six tablets) clonidine. After exceeded the allowed dose, other drugs may be associated. Initially, nifedipine (30mg/day to 60mg/day) according to the service routine. The goal of intervention is to maintain a systolic blood pressure below 170mmHg and diastolic pressure below 110mmHg, with the lowest possible dose. Thus, these medications will be increased should the need arise, according to measurements taken daily by the attending physician and the nursing staff.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertensive disorders of pregnancy;
  • Postpartum;
  • Age 18 to 45 years;
  • Very high blood pressure

Exclusion Criteria:

  • Cardiac disease;
  • Smoking;
  • Use of illicit drugs that may interfere with maternal hemodynamics;
  • Contraindications to the use of captopril: renal failure, chronic liver disease and hypersensitivity to the drug;
  • Contraindications to the use of clonidine: sinus node disease, chronic liver disease and hypersensitivity to the drug;
  • Inability to receive postpartum oral medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761916

Locations
Brazil
IMIP
Recife, Pernambuco, Brazil, 50070-550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Principal Investigator: Carlos Noronha, MD IMIP
  More Information

No publications provided by Instituto Materno Infantil Prof. Fernando Figueira

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leila Katz, MD pHD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT01761916     History of Changes
Other Study ID Numbers: CLONCAP
Study First Received: October 30, 2012
Last Updated: July 25, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
captopril, clonidine, pregnancy-induced hypertension,

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Captopril
Clonidine
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014