Sacubitril/Valsartan vs Lifestyle in Hypertrophic Cardiomyopathy (SILICOFCM)
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|ClinicalTrials.gov Identifier: NCT03832660|
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Cardiomyopathy||Behavioral: Lifestyle Drug: Sacubitril/Valsartan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||May 3, 2019|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Active Comparator: Lifestyle
Lifestyle intervention will consist of two integrated components i.e. physical activity and dietary supplementation with inorganic nitrate. The physical activity component aims to increase daily physical activity level by at least 2000 steps/day from baseline (e.g. walking for approximately 30 minutes), at least 5-7 days per week. The second component of the lifestyle intervention is a dietary supplementation with inorganic nitrate. A single dose of inorganic nitrate given in the form of concentrated nitrate-rich beetroot juice (NO3-, BEET IT Sport, James White Drinks Ltd., Ipswich, UK) containing 6 mmol of NO3- in 70 ml bottle.
A 4-month lifestyle intervention will consist of two integrated components i.e. physical activity and dietary supplementation with inorganic nitrate. The physical activity component aims to increase daily physical activity level by at least 2000 steps/day from baseline (e.g. walking for approximately 30 minutes), at least 5-7 days per week. The second component of the lifestyle intervention is a dietary supplementation with inorganic nitrate. A single dose of inorganic nitrate given in the form of concentrated nitrate-rich beetroot juice (NO3-, BEET IT Sport, James White Drinks Ltd., Ipswich, UK) containing 6 mmol of NO3- in 70 ml bottle.
Other Name: Physical acitivity and dietary nitrate
Active Comparator: Sacubitril/Valsartan
Sacubitril / Valsartan as a pharmacological agent shall be studied to verify its effects on cardiac morphology and physiology of hypertrophic cardiomyopathy patients.
Angiotensin receptor neprilysin inhibitor Sacubitril / Valsartan: The treatment period begins on day 1 with initial dosing of sacubitril/valsartan, followed by uptitration every 2 to 4 weeks to the target dose of 97/103 mg twice daily. 3 doses of sacubitril/valsartan available throughout the study are 24/26 mg, 49/51 mg, and 97/103 mg, each taken by mouth twice daily. If the patient discontinues the study medication, the patient is advised to return to the clinic for an end-of-study visit. Patients undergo treatment for 4 months.
Other Name: Pharmacological
No Intervention: Usual Care
The participants in control group do not undertake lifestyle or sacubitril / valsartan intervention.
- Peak Oxygen Consumption (ml/kg/min) [ Time Frame: 4 months ]Change in exercise tolerance i.e. peak oxygen consumption and anaerobic threshold post intervention
- Left ventricular mass (grams) [ Time Frame: 4 months ]The size of the left ventricle
- LVOT obstruction [ Time Frame: 4 months ]Degree of left ventricular outflow tract obstruction.
- LVEF (%) [ Time Frame: 4 months ]Left ventricular ejection fraction
- Minnesota Living with Heart Failure questionnaire [ Time Frame: 4 months ]Quality of Life (score range from 0 to 105)
- SF36 questionnaire [ Time Frame: 4 months ]Quality of Life RAND 36-Item Health Survey (score range from 0 to 100)
- E/A ratio [ Time Frame: 4 months ]Early to late filling ratio
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): NCT03832660
|Contact: Dr Djordje G Jakovljevic||+44 191 208 email@example.com|
|Contact: Dr Guy A MacGowan||+44 191 233 firstname.lastname@example.org|
|University Hospital Regensburg||Not yet recruiting|
|Contact: Dr Lars Maier email@example.com|
|Contact: Dr Maria Tafelmeier firstname.lastname@example.org|
|Azienda Ospedaliero Universitaria Careggi Florence||Not yet recruiting|
|Contact: Dr Iacopo Olivotto email@example.com|
|Contact: Dr Fausto Barlocco firstname.lastname@example.org|
|University of Belgrade Faculty of Medicine||Not yet recruiting|
|Contact: Dr Dejana Popovic email@example.com|
|Contact: Dr Arsen Ristic firstname.lastname@example.org|
|Institute of Cardiovascular Diseases of Vojvodina||Recruiting|
|Sremska Kamenica, Serbia|
|Contact: Dr Lazar Velicki email@example.com|
|Contact: Dr Andrej Preveden firstname.lastname@example.org|
|Newcastle University, Faculty of Medical Sciences, Clinical Research Facility, Royal Victoria Infirmary; Newcastle upon Tyne Hospitals NHS Foundation Trust||Recruiting|
|Newcastle Upon Tyne, England, United Kingdom, NE2|
|Contact: Dr Djordje G Jakovljevic +44 191 20 88257 email@example.com|
|Contact: Dr Guy A MacGowan +44 191 233 6161 firstname.lastname@example.org|
|Sub-Investigator: Dr Paul Brennan|
|Sub-Investigator: Dr Christopher Eggett|
|Sub-Investigator: Dr Nduka Okwose|
|Principal Investigator:||Dr Djordje G Jakovljevic||Newcastle University Faculty of Medical Sciences, Clinical Research Facility, Newcastle upun Tyne Hospitals NHS Foundation Trust|