Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

"Hjerteloeftet" ("HeartLift"). Interaction For Preventing Cardiovascular Disease (HeartLift)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741428
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
LHL Helse

Brief Summary:
Early interventions to promote physical activity, dietary lifestyle changes and optimal medication for cardiovascular risk factor reduction - 3 years follow-up. A randomized Clinical Trial.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: Intervention (INT1) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: "Hjerteloeftet". Early Interventions to Promote Physical Activity, Dietary Lifestyle Changes and Optimal Medication for Cardiovascular Risk Factor Reduction in Over 3 Years Follow-up.
Study Start Date : November 2012
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Arm Intervention/treatment
Active Comparator: Intervention (INT1)
The participants will join a 5-days course at the Feiring Heart Clinic.
Behavioral: Intervention (INT1)

The course Program at the Feiring Heart Clinic will:

Clinical examination and ergospirometric testing, optimizing both treatment and prophylactic medication. Promoting physical Activity, changes in lifestyle, dietary changes/weight reduction, smoking cessation. In the follow-up period the participants will be contacted and report regularly through a web-based secure program (MedAxess)(such as: Activity-, dietary- and smoking habits). Each participant will have their own Mentor, helping keeping up the motivation. They will also meet regularly at the local doctors Office which reports relevant parameters to the Project (such as weight, BP, Lipoproteins, blood glucose/HbA1C)


No Intervention: Control (KTR1)
The participants in the Control Group will receive care as usual at their local Doctors Office
Active Comparator: Subgroup Intervention (INT2)
Subgroup of 200 participants from the (INT1)where multiple, known CVD risk factors are studied: Physical Activity, Physical Condition (O2-consumption), Quality of life, Biochemical markers (fasting Glucose, Insulin, Apo Lipoprotein A (ApoA), Apo Lipoprotein B (ApoB), micro-C reactive protein (CRP), Total-, LDL- and HDL-cholesterol, Triglycerides and HbA1C.
Behavioral: Intervention (INT1)

The course Program at the Feiring Heart Clinic will:

Clinical examination and ergospirometric testing, optimizing both treatment and prophylactic medication. Promoting physical Activity, changes in lifestyle, dietary changes/weight reduction, smoking cessation. In the follow-up period the participants will be contacted and report regularly through a web-based secure program (MedAxess)(such as: Activity-, dietary- and smoking habits). Each participant will have their own Mentor, helping keeping up the motivation. They will also meet regularly at the local doctors Office which reports relevant parameters to the Project (such as weight, BP, Lipoproteins, blood glucose/HbA1C)


No Intervention: Subgroup control (KTR2)
Subgroup of 200 participants from the (KTR1)where multiple, known CVD risk factors are studied: Physical Activity, Physical Condition (O2-consumption), Quality of life, Biochemical markers (fasting Glucose, Insulin, Apo Lipoprotein A (ApoA), Apo Lipoprotein B (ApoB), micro-C reactive protein (CRP), Total-, LDL- and HDL-cholesterol, Triglycerides and HbA1C.



Primary Outcome Measures :
  1. Change in risk score (NORRISK) [ Time Frame: 3 Years after end of inclusion ]

    Major End Point

    Change in risk score (Norrisk, Procam and Framingham) between baseline and after three years of intervention.



Secondary Outcome Measures :
  1. Weight and Body Mass Index (BMI) [ Time Frame: 3 Years after end of inclusion ]
    Change of weight in kg and BMI between baseline and three years of follow-up.

  2. Waist circumference [ Time Frame: 3 Years after end of inclusion ]
    Change of waist circumference in cm. between baseline and three years of follow-up.

  3. Serum Lipids [ Time Frame: 3 Years after end of inclusion ]
    Change of serum Lipids in mmol/l (LDL-, HDL-, Total-Cholesterol and Triglycerides) between baseline and three years of follow-up.

  4. Blood Pressure [ Time Frame: 3 Years after end of inclusion ]
    Change of Blood Pressure in mmHG between baseline and three years of follow-up.

  5. HbA1C [ Time Frame: 3 Years after end of inclusion ]
    Change of HbA1C in % between baseline and three years of follow-up.


Other Outcome Measures:
  1. Interaction outcome [ Time Frame: 3 Years after end of inclusion ]
    The Interaction between primary (local) and secondary (hospital) Health Service/-care) will be evaluated through a questionnaire.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All male and female between the age of 35 to 67 with middle or high 10 years risk estimate are included.

  • >= 0.5% for persons under the age of 50 years
  • >= 2.5% for persons between 50-59 years
  • >= 5% for persons > 60 years

Exclusion Criteria:

  • Previous cardiovascular disease (CHD ; peripherical atherosclerosis, deep venous thrombosis /pulmonary embolism, congenital heart disease, presence of valvular heart disease).
  • Lung disease restricting usual physical activity .
  • Serious psychological problems (that hinders the participation in the study)
  • All kind of disease restricting performing adequate physical activity .
  • Presence of cancer shortening drastically survival.

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): NCT01741428


Locations
Layout table for location information
Norway
LHL-Hospital Gardermoen
Jessheim, Norway, N-2051
Sponsors and Collaborators
LHL Helse
Investigators
Layout table for investigator information
Principal Investigator: Hilde Bergum, MD LHL Hospital Gardermoen
Publications:

Layout table for additonal information
Responsible Party: LHL Helse
ClinicalTrials.gov Identifier: NCT01741428    
Other Study ID Numbers: 2011/561a(REK-LHL)
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Keywords provided by LHL Helse:
CVD Risk score
Physical activity
Overweight
Cholesterol
LDL-Cholesterol
HDL-Cholesterol
Triglycerides
HbA1C
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases