Status:
COMPLETED
Lifestyle and Pharmacological Interventions in Hypertrophic Cardiomyopathy
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborating Sponsors:
University Hospital Regensburg
Assistance Publique - Hôpitaux de Paris
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The overall aim of this project is to establish potential benefits of a novel lifestyle (physical activity and dietary nitrate) and pharmacological (angiotensin receptor neprilysin inhibitor) interven...
Detailed Description
Background and Rationale for the Study: Hypertrophic cardiomyopathy (HCM) is the most common hereditary cardiac disease, affecting one in 500 individuals. The predominant cause is mutation of genes t...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of obstructive and/or non-obstructive hypertrophic cardiomyopathy.
- Agreement to be a participant in the study protocol and willing/able to return for follow-up.
- Able to provide written informed consent
Exclusion
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention)
- Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms.
- Resting blood pressure greater than 180/100 mm Hg.
- Systolic blood pressure lower than 100 mmHg
- Hypotensive response to exercise testing (≥20 mmHg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure ≥20 mmHg).
- Use of angiotensin converting Enzyme inhibitors or angiotensin receptor blockers.
- Resting left ventricular outflow tract gradient \> 50 mm Hg.
- Left ventricular ejection fraction of less than 50% by echocardiography.
- Implanted pacemaker or cardiodefibrilator in the last 3 months or scheduled.
- Renal insufficiency with a glomerular filtration rate of less than 30 mL/min per 1.73m2.
- Present or planned pregnancy.
- Life expectancy less than 12 months.
- Body mass index \>40 kg/m2.
- A history of exercise induced syncope or ventricular arrhythmias.
- Inability to exercise due to orthopaedic or other non-cardiovascular limitations.
- Use of other investigational drugs at the time of enrolment.
- Any surgical or medical condition that in the opinion of the investigator may place the patient at higher risk from his/her participation in the study or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- History or presence of any other disease with a life expectancy of \<3 years
- History of noncompliance to medical regimens and patients who are considered potentially unreliable.
- History or evidence of drug or alcohol abuse within the past 12 months.
- History of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin or localized prostate cancer), treated or untreated, within the past 2 years, regardless of whether there is evidence of local recurrence or metastases.
- Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and AF or atrial flutter with a resting ventricular rate \>110 beats per minute.
- Participation in competitive or organized sport activities (such as football, basketball, rugby, hockey, etc), burst activity (such as sprinting, racket sports, etc) or heavy isometric exercise (such as body building or bench-pressing) or opposition of refraining from the same for the duration of the study
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05366101
Start Date
April 1 2019
End Date
March 31 2022
Last Update
May 9 2022
Active Locations (1)
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1
Newcastle NHS
Newcastle, United Kingdom