Clinical Trials Logo
  1. Home
  2. Hypertrophic Cardiomyopathy
  3. NCT01447654
  4. Details
NCT01447654 Clinical Trial

Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

— INHERIT  

Official title:
INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01447654
Other study ID # 2011-001191-19
Secondary ID
Status Completed
Phase Phase 2
First received October 4, 2011
Last updated July 8, 2014
Start date November 2011
Est. completion date June 2014

Study information
Verified date July 2014
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

Objective The objective of the study is to assess the structural and functional cardiac effects of treatment with losartan in patients with hypertrophic cardiomyopathy (HCM).

Design The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is 12 months. 130 patients with HCM will be included in predefined subgroups. Genotype positive relatives with borderline hypertrophy (> 13 mm) will also be included. Data on individuals with borderline hypertrophy will be analysed separately from the rest of the cohort.

Primary outcome Ventricular hypertrophy assessed as left ventricular mass and maximal wall thickness.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hypertrophic cardiomyopathy

- > 18 years

- Sinus rhythm

Exclusion Criteria:

- EF < 50 %

- Treatment with RAS-inhibitor

- Contraindications to losartan

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Losartan
100 mg for 12 months.
• Placebo
100 mg for 12 months.

Locations
Country Name City State
Denmark Department of cardiology, Rigshospitalet. Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Henning Bundgaard

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypertrophy of left ventricle Left ventricular mass. Maximal wall thickness. 12 months No
See also
  Status Clinical Trial Phase
Terminated NCT03249272 - Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve Phase 4
Recruiting NCT03846297 - Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Completed NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study
Active, not recruiting NCT01225978 - Refining Information Technology Support for Genetics in Medicine N/A
Completed NCT00001632 - Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease N/A
Completed NCT00001534 - Long Term Effects of Enalapril and Losartan on Genetic Heart Disease N/A
Enrolling by invitation NCT04050579 - OPIE in the Thin Interventricular Septum N/A
Completed NCT03537183 - Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? N/A
Completed NCT02590809 - Hypertrophic Cardiomyopathy Symptom Release by BX1514M Phase 2
Completed NCT00001396 - Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop... Phase 1
Active, not recruiting NCT03723655 - A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM Phase 2/Phase 3
Completed NCT05135871 - Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects Phase 1
Completed NCT04129905 - Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies N/A
Recruiting NCT03061994 - Metabolomic Study of All-age Cardiomyopathy N/A
Completed NCT02234336 - Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
Recruiting NCT00221832 - Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases N/A
Not yet recruiting NCT03706001 - Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression N/A
Recruiting NCT06169358 - Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy
Not yet recruiting NCT04090437 - HCM-AF Ablation With ACUTUS N/A
Completed NCT04402268 - Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy