Chronic Heart FailurePhase 4NCT06706791
Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
A Phase 4 study testing Empagliflozin 10 MG in people with Chronic Heart Failure, run by Fazaia Ruth Pfau Medical College at 1 site in Pakistan.
Trial summary
Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years at time of screening.
- Both Men and women are included in study.
- Patients with chronic heart failure and currently categorized in class II-IV heart failure as per NHYA classification having ejection fraction less than 40%.
- Patients having NT- proBNP levels greater than 25pg/ml.
- Diabetic patient diagnosed (HbA1c > 6.5mg/dl) and currently taking antidiabetic medicine.
Who cannot join
- Pregnant female.
- Patient with end stage renal disease (ESRD).
- Patient with acute decompensated heart failure.
- Acute coronary syndrome patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Fazaia Ruth Pfau Hospital
Karachi, Sindh, 75120
Dr Masood Ahmed, MBBS Phd, 03002922361, principal.frpmc@mail.au.edu.pk
DR Asghar Mehdi, MBBS Phd, 03008228284, drasgharmehdi@gmail.com
About this study
Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status.
As per American College of Cardiology (ACC)/American Heart Association (AHA) Empagliflozin is recommended in both diabetic and non-diabetic HF (especially beneficial in patients with HFrEF and HFpEF).
Read more
The aim of my study is to assess the impact of Empagliflozin on quality of life in Pakistani patients, considering the genetic, environmental and cultural factors.
The study will also explore whether Empagliflozin can offer cost-effective option for managing chronic heart failure and diabetes, potentially reducing the economic burden on both patients and health care system.
Read the detailed description
Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status.
This is a comparative clinical study with randomized groups. Participants will be allocated to either the Empagliflozin group or the placebo group alongside standard therapy.
Blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio.
Empagliflozin Group: taking Empagliflozin 10mg once daily per oral along with standard treatment. Their quality of life assessed by using Kansas City Cardiomyopathy questionnaire. Placebo Group: Identical placebo tablets, following the same dose and schedule as the Empagliflozin group along with standard treatment of chronic heart failure.
Duration is of18 months. Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
- Conditions
- Chronic Heart Failure
- Being tested
- Empagliflozin 10 MG
- Keywords
- CHF DM type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Horizon,
participants will be divided in two groups one group will empagliflozin 10mg once daily along with standard treatment secong group receiving placebo once daily along with standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm, Palcebo controlled group | Experimental | Experimental arm, taking empagliflozin 10mg once daily along with standard treatment. Receives: Drug: Empagliflozin 10 MG |
| Palcebo controlled group | Placebo comparator | Palcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment. Receives: Drug: Empagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in Kansas city cardiomyopathy questionnaire scoring
Primary outcome measure will be the improvement in quality of life indicating by change in Kansas City cardiomyopathy questionnaire (KCCQ) scoring. higher value indicates better results.
Measured: 18 months
Secondary outcomes (1)
assessment of NT-pro-BNP levels.
Secondary outcome measures will include the change in NT-pro-BNP levels.lower values indicates better results
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a comparative clinical study with randomized groups. Participants will be allocated to either the Empagliflozin group or the placebo group alongside standard therapy. Blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio. Empagliflozin Group: taking Empagliflozin 10mg once daily per oral along with standard treatment. Their quality of life assessed by using Kansas City Cardiomyopathy questionnaire. Placebo Group: Identical placebo tablets, following the same dose and schedule as the Empagliflozin group along with standard treatment of chronic heart failure. Duration 18 months Setting Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fazaia Ruth Pfau Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tooba Riaz, Fazaia Ruth Pfau Medical College
- Investigators
- Tooba Riaz, MBBS, Principal investigator, Fazaia Ruth Pfau Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706791
- Sponsor's protocol ID
- FRPMC-IRB-2024-64
- Other IDs
- FMC,Air university
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it will be shared if required by relevent authorities
Publications
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Dunlay SM, Roger VL, Redfield MM. Epidemiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2017 Oct;14(10):591-602. doi: 10.1038/nrcardio.2017.65. Epub 2017 May 11.
PubMed 28492288Januzzi JL Jr, Zannad F, Anker SD, Butler J, Filippatos G, Pocock SJ, Ferreira JP, Sattar N, Verma S, Vedin O, Schnee J, Iwata T, Cotton D, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Sep 28;78(13):1321-1332. doi: 10.1016/j.jacc.2021.07.046.
PubMed 34556318Januzzi JL Jr, Ahmad T, Mulder H, Coles A, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Mark DB, Pina IL, Passmore G, Whellan DJ, Cooper LS, Leifer ES, Desvigne-Nickens P, Felker GM, O'Connor CM. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 3;74(9):1205-1217. doi: 10.1016/j.jacc.2019.06.055.
PubMed 31466618Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PubMed 26378978Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
PubMed 35379503Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.
PubMed 32865377Stubblefield WB, Jenkins CA, Liu D, Storrow AB, Spertus JA, Pang PS, Levy PD, Butler J, Chang AM, Char D, Diercks DB, Fermann GJ, Han JH, Hiestand BC, Hogan CJ, Khan Y, Lee S, Lindenfeld JM, McNaughton CD, Miller K, Peacock WF, Schrock JW, Self WH, Singer AJ, Sterling SA, Collins SP. Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department. Circ Cardiovasc Qual Outcomes. 2021 Oct;14(10):e007956. doi: 10.1161/CIRCOUTCOMES.121.007956. Epub 2021 Sep 24.
PubMed 34555929
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
- ClinicalTrials.gov ID
- NCT06706791
- Acronym / sponsor ID
- FRPMC-IRB-2024-64
- Conditions
- Chronic Heart Failure
- Keywords
- CHF DM type II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fazaia Ruth Pfau Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status.
As per American College of Cardiology (ACC)/American Heart Association (AHA) Empagliflozin is recommended in both diabetic and non-diabetic HF (especially beneficial in patients with HFrEF and HFpEF).
The aim of my study is to assess the impact of Empagliflozin on quality of life in Pakistani patients, considering the genetic, environmental and cultural factors.
The study will also explore whether Empagliflozin can offer cost-effective option for managing chronic heart failure and diabetes, potentially reducing the economic burden on both patients and health care system.
Detailed description
Effect of Empagliflozin on Quality of Life in patient of Chronic Heart Failure with Diabetes Mellitus Type II. As per ESC Guidelines Empagliflozin is recommended as part of the first-line treatment for HFrEF, irrespective of diabetes status.
This is a comparative clinical study with randomized groups. Participants will be allocated to either the Empagliflozin group or the placebo group alongside standard therapy.
Blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio.
Empagliflozin Group: taking Empagliflozin 10mg once daily per oral along with standard treatment. Their quality of life assessed by using Kansas City Cardiomyopathy questionnaire. Placebo Group: Identical placebo tablets, following the same dose and schedule as the Empagliflozin group along with standard treatment of chronic heart failure.
Duration is of18 months. Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a comparative clinical study with randomized groups. Participants will be allocated to either the Empagliflozin group or the placebo group alongside standard therapy. Blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio. Empagliflozin Group: taking Empagliflozin 10mg once daily per oral along with standard treatment. Their quality of life assessed by using Kansas City Cardiomyopathy questionnaire. Placebo Group: Identical placebo tablets, following the same dose and schedule as the Empagliflozin group along with standard treatment of chronic heart failure. Duration 18 months Setting Will take place in Fazaia Ruth Pfau medical college and hospital and NICVD hospital Karachi.
| Arm | Type | Receives |
|---|---|---|
| experimental arm, Palcebo controlled group | Experimental | Drug: Empagliflozin 10 MGExperimental arm, taking empagliflozin 10mg once daily along with standard treatment. |
| Palcebo controlled group | Placebo comparator | Drug: Empagliflozin 10 MGPalcebo controlled group patient receiving placebo to compare with empagliflozin along with standard treatment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-70 years at time of screening.
- Both Men and women are included in study.
- Patients with chronic heart failure and currently categorized in class II-IV heart failure as per NHYA classification having ejection fraction less than 40%.
- Patients having NT- proBNP levels greater than 25pg/ml.
- Diabetic patient diagnosed (HbA1c > 6.5mg/dl) and currently taking antidiabetic medicine.
Key exclusion criteria (4 listed)
- Pregnant female.
- Patient with end stage renal disease (ESRD).
- Patient with acute decompensated heart failure.
- Acute coronary syndrome patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: Horizon,participants will be divided in two groups one group will empagliflozin 10mg once daily along with standard treatment secong group receiving placebo once daily along with standard treatment. | Drug | Palcebo controlled group, experimental arm, Palcebo controlled group |
Primary outcome
improvement in Kansas city cardiomyopathy questionnaire scoring
Time frame: 18 months
Primary outcome measure will be the improvement in quality of life indicating by change in Kansas City cardiomyopathy questionnaire (KCCQ) scoring. higher value indicates better results.
1 secondary outcome
assessment of NT-pro-BNP levels.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Background: PubMed 28492288Dunlay SM, Roger VL, Redfield MM. Epidemiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2017 Oct;14(10):591-602. doi: 10.1038/nrcardio.2017.65. Epub 2017 May 11.
- Background: PubMed 34556318Januzzi JL Jr, Zannad F, Anker SD, Butler J, Filippatos G, Pocock SJ, Ferreira JP, Sattar N, Verma S, Vedin O, Schnee J, Iwata T, Cotton D, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Sep 28;78(13):1321-1332. doi: 10.1016/j.jacc.2021.07.046.
- Background: PubMed 31466618Januzzi JL Jr, Ahmad T, Mulder H, Coles A, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Mark DB, Pina IL, Passmore G, Whellan DJ, Cooper LS, Leifer ES, Desvigne-Nickens P, Felker GM, O'Connor CM. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 3;74(9):1205-1217. doi: 10.1016/j.jacc.2019.06.055.
- Results publication: PubMed 26378978Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
- Results publication: PubMed 35379503Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
- Results publication: PubMed 32865377Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Bohm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.
- Results publication: PubMed 34555929Stubblefield WB, Jenkins CA, Liu D, Storrow AB, Spertus JA, Pang PS, Levy PD, Butler J, Chang AM, Char D, Diercks DB, Fermann GJ, Han JH, Hiestand BC, Hogan CJ, Khan Y, Lee S, Lindenfeld JM, McNaughton CD, Miller K, Peacock WF, Schrock JW, Self WH, Singer AJ, Sterling SA, Collins SP. Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department. Circ Cardiovasc Qual Outcomes. 2021 Oct;14(10):e007956. doi: 10.1161/CIRCOUTCOMES.121.007956. Epub 2021 Sep 24.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No. it will be shared if required by relevent authorities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tooba Riaz, MBBS principal investigator
Fazaia Ruth Pfau Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 10 MG in people with Chronic Heart Failure, run by Fazaia Ruth Pfau Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tooba Riaz, MBBS (03333231665 ext. 316, drtoobariaz@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in Kansas city cardiomyopathy questionnaire scoring (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06706791, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.