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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03832660
Date of registration: 01/02/2019
Prospective Registration: Yes
Primary sponsor: Newcastle University
Public title: Sacubitril/Valsartan vs Lifestyle in Hypertrophic Cardiomyopathy SILICOFCM
Scientific title: Clinical and Genetic Determinants of Disease Progression and Response to Sacubitril/Valsartan vs Lifestyle (Physical Activity and Dietary Nitrate) in Patients With Hypertrophic Cardiomyopathy
Date of first enrolment: May 3, 2019
Target sample size: 240
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03832660
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Germany Italy Serbia United Kingdom
Contacts
Name:     Dr Djordje G Jakovljevic
Address: 
Telephone: +44 191 208 8257
Email: djordje.jakovljevic@newcastle.ac.uk
Affiliation: 
Name:     Dr Djordje G Jakovljevic
Address: 
Telephone:
Email:
Affiliation:  Newcastle University Faculty of Medical Sciences, Clinical Research Facility, Newcastle upun Tyne Hospitals NHS Foundation Trust
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hypertrophic Cardiomyopathy
Intervention(s)
Behavioral: Lifestyle
Drug: Sacubitril/Valsartan
Primary Outcome(s)
Peak Oxygen Consumption (ml/kg/min) [Time Frame: 4 months]
Secondary Outcome(s)
E/A ratio [Time Frame: 4 months]
Left ventricular mass (grams) [Time Frame: 4 months]
LVEF (%) [Time Frame: 4 months]
LVOT obstruction [Time Frame: 4 months]
Minnesota Living with Heart Failure questionnaire [Time Frame: 4 months]
SF36 questionnaire [Time Frame: 4 months]
Secondary ID(s)
252015
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Azienda Ospedaliero-Universitaria Careggi
Institute for Cardiovascular Diseases of Vojvodina
University Hospital Regensburg
University of Belgrade
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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