Heart FailureNCT04942548
Reverse HFpEF: Ketogenic Reversal of Heart Failure With Preserved Ejection Fraction Study
A study testing Ketogenic Diet in people with Heart Failure, run by National Jewish Health at 2 sites in United States.
Trial summary
This protocol is a prospective pilot study utilizing the intervention of a medically supervised, registered nurse and registered diabetes educator coached low-carbohydrate, ketogenic diet to examine the impact it has as a treatment for heart failure with preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2019to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age 21-80) who meet clinical signs and symptoms of heart failure based on clinical assessment.
- The subject must meet at least one of the following hemodynamic criteria for HFpEF of PH-HFpEF by right heart catheterization (RHC) within 6 months of screening visit;
- HFpEF:
- At rest: mean pulmonary artery occlusions pressure (PAOP) > 15, pulmonary vascular resistance (PVR) < 3 Wood Units, or
- HFpEF with fluid challenge, defined as increase in PAOP post 500 cc fluid bolus: mean PAOP > 18, PVR < 3 Wood Units, or
- HFpEF with exercise, defined as peak mean PAOP > 17, PVR < 3 Wood Units if age < 50 or peak mean PAOP > 19 and PVR < 3 Wood Units if age >= 50
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- PH-HFpEF:
- At rest: mean pulmonary artery occlusion pressure (PAOP) > 15, mean pulmonary artery pressure (PAP) >= 25, pulmonary vascular resistance (PVR) > 3 Wood Units, or
- PH-HFpEF with fluid challenge, defined as increase in PAOP post 500 cc fluid bolus: mean PAOP > 18, mean PAP >= 25, PVR > 3 Wood Units, or
- PH-HFpEF with exercise, defined as peak mean PAOP > 17, peak mean PAP > 30, peak PVR > 1.34 Wood Units if age < 50 or peak mean PAOP > 19, peak mean PAP > 33, and PVR < 2.1 Wood Units if age >= 50
- The subject also must meet criteria for metabolic syndrome, defined as: Abdominal obesity (BMI > 30 kg/m2 or abdominal obesity, waist circumference > 102 cm men, > 88 cm women) AND 2 of the following;
- Currently being treated for systemic hypertension or blood pressure (BP) >= 135/85 b. Glucose intolerance with diagnosis of type 2 diabetes, or fasting blood glucose 110-125 mg/dL or hemoglobin A1c > 6% c. Triglycerides >= 150, or on treatment for high triglycerides d. HDL < 40 men, < 50 women, or on treatment for high triglycerides
- If the subject is on pulmonary hypertension specific vasodilators, they must be on stable medical therapy without changes to pulmonary vasodilator medication within 3 months prior to screening visit.
- The subject must have also had a cardiopulmonary exercise test within 6 months of screening visit.
- The subject must have also had an echocardiogram within 6 months of screening visit.
- The subject must have demonstrated stable weight (less that 5% weight loss) 3 months prior to screening visit. (They cannot already be losing weight).
- The subject owns and uses a smartphone or tablet.
- Must speak English
Who cannot join
- The subject is already on a significant weight loss trajectory prior to study entry.
- The subject cannot be on an alternative diet plan or strategy (e.g., Weight Watchers, Nutrisystem, Ornish).
- Left ventricular ejection fraction < 50%.
- Severe valvular disease by echocardiogram or dysfunctional prosthetic valve.
- Active pericardial disease (moderate or large pericardial effusion or constrictive pericarditis).
- Active coronary ischemia defined by abnormal stress test, angiogram, or coronary CT angiography per investigator.
Show all 20Show fewer
- Prolonged corrected QT interval (QTc) > 450 ms
- Significant lung disease on pulmonary function tests (PFT's) within the 6 months of screening visit, (Both post-bronchodilator values and pre-bronchodilator values must meet exclusion criteria. If either post- or pre-bronchodilator values do not, the subject may be included) defined as either:
- Irreversible obstructive airways disease (post-bronchodilator forced expiratory volume/forced vital capacity (FEV1/FVC) < 70% predicted) or
- Restrictive lung disease (FVC < 70% predicted. If total lung capacity (TLC) is >= 70%, it is acceptable to have an FVC of < 70%) or
- More than mild radiographic pulmonary disease as determine don CT scan within the past 2 years per investigator.
- History of non-adherence to diuretics within 3 months of screening visit.
- History or recurrent severe hypokalemia, potassium < 3.0 mg/dL.
- History of kidney stones, gout, or gallbladder disease unless in the opinion of the investigator it will not impact the safety of the patient
- C-peptide < 0.5 ng/mL (increased risk of diabetic ketoacidosis (DKA))
- Uncorrected anemia (hemoglobin < 10 g/dL).
- Unable to participate in the comprehensive ketogenic diet program, including biometric data acquisition and data entry (glucometer self-stick and smartphone use).
- Unable or unwilling to prepare meals for self.
- Unable to perform quantitative cardia testing regimen (cardiopulmonary exercise testing, 6-minute walk).
- Subject is pregnant or planning to become pregnant in the next 14 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Jewish Health and University of Colorado Denver
Denver, Colorado, 80206
Saint Joseph Hospital
Denver, Colorado, 80218
About this study
This protocol is a prospective pilot study utilizing the intervention of a medically supervised, registered nurse and registered diabetes educator coached low-carbohydrate, ketogenic diet to examine the impact it has as a treatment for heart failure with preserved ejection fraction.
- Conditions
- Heart Failure
- Being tested
- Ketogenic Diet
- Keywords
- obese, keto, diet, cardiac
- Medical subject headings
- Heart Failure, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
Ketogenic diet intervention that is high in fat and low in carbohydrates, causing the body to induce a state of metabolic ketosis, whereby fat is broken down into ketones to provide an energy source for the body.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF | Experimental | Patients diagnosed with obesity related heart failure with preserved ejection fraction(HFpEF) Receives: Other: Ketogenic Diet |
| PH-HFpEF | Experimental | Patients diagnosed with obesity related pulmonary hypertension heart failure with preserved ejection fraction (PH-HFpEF) Receives: Other: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
MLHFQ Questionnaire
Change in score on the Minnesota Living with Heart Failure Quality of Life (MLHFQ) Questionnaire for the HFpEF cohort.
- Max. Score = 105
- Min. Score = 0
- A reduced score means improvement of heart failure symptoms; better outcome
Measured: 6 Months
PAH-SYMPACT Questionnaire
Change in score on the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire for the PH-HFpEF cohort.
- Max. Score = 89
- Min. Score = 0
- A reduced score means improvement of pulmonary hypertension heart failure symptoms; better outcome
Measured: 6 Months
Secondary outcomes (36)
Change in Metabolic Health: Weight
Weight in kilograms (kg)
Measured: 6 Months
Change in Metabolic Health: Glucose
Glucose in milligrams per deciliter (mg/dL)
Measured: 6 Months
Change in Metabolic Health: Insulin
Insulin in microinternational unit per milliliter (uIU/mL)
Measured: 6 Months
Change in Metabolic Health: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Insulin and glucose are multiplied then divided by 405 to report HOMA-IR
Measured: 6 Months
Change in Metabolic Health: Albumin
Albumin in grams per deciliter (g/dL)
Measured: 6 Months
Change in Metabolic Health: Bilirubin total
Bilirubin total in milligrams per deciliter (mg/dL)
Measured: 6 Months
Change in Metabolic Health: Alanine Transaminase (ALT)
ALT in units per liter (U/L)
Measured: 6 Months
Change in Metabolic Health: Aspartate Aminotransferase (AST)
AST in units per liter (U/L)
Measured: 6 Months
Change in Metabolic Health: Alkaline Phosphatase (ALP)
ALP in units per liter (U/L)
Measured: 6 Months
Change in Metabolic Health: High Sensitivity C-Reactive Protein (HS-CRP)
HS-CRP in milligrams per deciliter (mg/dL)
Measured: 6 Months
Change in Metabolic Health: Triglycerides
triglyceride in milligrams per deciliter (mg/dL)
Measured: 6 Months
Change in Metabolic Health: High Density Lipoprotein (HDL)
HDL in milligrams per deciliter (mg/dL)
Measured: 6 Months
Change in Metabolic Health: Hemoglobin A1c
hemoglobin A1c in percent (%)
Measured: 6 Months
Change in Metabolic Health: Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: 6 Months
Changes in Physical Function: 6 Minute Walk Test (6MWT)
6-minute walk test is reported in meters (m) of how far a subject walks in 6 minutes
Measured: 6 Months
Changes in Physical Function: Maximum Oxygen Consumption (VO2max)
VO2 max is reported in liters per minute (L/min) while performing a cardiopulmonary exercise test (CPET)
Measured: 6 Months
Changes in Physical Function: Maximum Work
Maximum work achieved while performing a cardiopulmonary exercise test (CPET) is reported in watts (W)
Measured: 6 Months
Changes in Physical Function: 30 Second Sit-to-Stand test (30s STS)
30s STS is reported in quantity of how many times the subject can come to a full stand from a seated position in 30 seconds (s)
Measured: 6 Months
Changes in Physical Function: Leg Press - 1 Repetition Maximum
Leg press is reported in kilograms (kg)
Measured: 6 Months
Changes in Physical Function: Chest Press - 1 Repetition Maximum
Chest press is reported in kilograms (kg)
Measured: 6 Months
Changes in Physical Function: Leg Extension - 1 Repetition Maximum
Leg extension is reported in kilograms (kg)
Measured: 6 Months
Cardiac Remodeling: Changes in the Left Ventricle (LV) size
This is determined by the internal diameter measurement of the LV, reported in centimeters (cm) from a subject performed echocardiogram
Measured: 6 Months
Cardiac Remodeling: Changes in the Left Ventricle (LV) thickness
This is determined by a measurement of the LV wall, reported in millimeters (mm) from an echocardiogram.
Measured: 6 Months
Cardiac Remodeling: Changes in the Left Ventricle (LV) mass
This is determined by a combination formula of the interventricular septum diastole (IVSd), left ventricle diastole (LVd), and posterior wall diastole (PWd), calculated by an echocardiogram and reported in grams (g).
Measured: 6 Months
Cardiac Remodeling: Changes in Left Atrium (LA) size
This is determined by the internal diameter measurement of the LA, reported in centimeters (cm) from a subject performed echocardiogram.
Measured: 6 Months
Cardiac Remodeling: Changes in Inferior Vena Cava (IVC) size
This is determined by the internal diameter perpendicular to the long axis of the IVC at the end-expiration, reported in centimeters (cm) from the echocardiogram.
Measured: 6 Months
Cardiac Remodeling: Changes in estimated Right Atrial Pressure (RAP)
This is determined by a combination equation subtracting the venous return (VR) from the central venous pressure (CVP), reported in millimeters of mercury (mmHg) from the echocardiogram.
Measured: 6 Months
Cardiac Remodeling: Changes in Right Ventricle Systolic Pressure (RVSP)
This estimates the pressure inside the artery that supplies the lung with blood, reported in millimeters of mercury (mmHg) from the echocardiogram.
Measured: 6 Months
Changes in the rate of mitral annulus velocity (e')
e' is reported in centimeters per second (cm/s) based on a subject performed echocardiogram
Measured: 6 Months
Changes in the ratio of transmitral early peak velocity (E) by pulsed wave Doppler over e' (E/e')
E/e' is reported as an integer based on the transmitral early peak velocity (E) over the mitral annulus velocity (e') from a subject performed echocardiogram.
Measured: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Right Atrial Pressure (RAP)
This is determined by a combination equation subtracting the venous return (VR) from the central venous pressure (CVP), reported in millimeters of mercury (mmHg) from the echocardiogram.
Measured: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Pulmonary Artery Pressure (PAP)
This is calculated from systolic, by Tricuspid Regurgitation maximum (TRmax) and diastolic, by Pulmonary Regurgitation-end velocity (PR-end) pulmonary artery pressures, reported in millimeters of mercury (mmHg) from the echocardiogram.
Measured: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Pulmonary Artery Occlusive Pressure (PAOP)
This is determined by the pressure value of the pulmonary artery once it's occluded during a Right Heart Catheterization (RHC), measured in millimeters of mercury (mmHg).
Measured: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Pulmonary Vascular Resistance (PVR)
Left Atrial Pressure (LAP), Pulmonary Artery Pressure (PAP) and Cardiac Output (CO) are combined to report the PVR in Wood Units (WU) from a Right Heart Catheterization (RHC).
Measured: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Cardiac Output (CO)
Stoke Volume (SV) and Heart Rate (HR) are combined to report CO in liters per minute (L/min) from the right heart catheterization.
Measured: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Cardiac Index (CI)
Cardiac Output (CO) and Body Surface Area (BSA) are combined to report CI in liters per minute per meters squared (L/min/m^2) from a Right Heart Catherization (RHC).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 Jul 2019
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darlene Kim, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942548
- Sponsor's protocol ID
- HS-3243 Keto
- Status last verified
- Apr 2024
- First submitted
- 25 May 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kodur N, Nguyen C, Tang WHW. Therapeutic Ketosis for Heart Failure: A State-of-the-Art Review. J Card Fail. 2025 Jul;31(7):1051-1061. doi: 10.1016/j.cardfail.2025.01.028. Epub 2025 Mar 3.
PubMed 40043832
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse HFpEF: Ketogenic Reversal of Heart Failure With Preserved Ejection Fraction Study
- ClinicalTrials.gov ID
- NCT04942548
- Acronym / sponsor ID
- HS-3243 Keto
- Conditions
- Heart Failure
- Keywords
- obese, keto, diet, cardiac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 28 Jun 2021 (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.
This protocol is a prospective pilot study utilizing the intervention of a medically supervised, registered nurse and registered diabetes educator coached low-carbohydrate, ketogenic diet to examine the impact it has as a treatment for heart failure with preserved ejection fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF | Experimental | Other: Ketogenic DietPatients diagnosed with obesity related heart failure with preserved ejection fraction(HFpEF) |
| PH-HFpEF | Experimental | Other: Ketogenic DietPatients diagnosed with obesity related pulmonary hypertension heart failure with preserved ejection fraction (PH-HFpEF) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adults (age 21-80) who meet clinical signs and symptoms of heart failure based on clinical assessment.
- The subject must meet at least one of the following hemodynamic criteria for HFpEF of PH-HFpEF by right heart catheterization (RHC) within 6 months of screening visit;
- HFpEF:
- At rest: mean pulmonary artery occlusions pressure (PAOP) > 15, pulmonary vascular resistance (PVR) < 3 Wood Units, or
- HFpEF with fluid challenge, defined as increase in PAOP post 500 cc fluid bolus: mean PAOP > 18, PVR < 3 Wood Units, or
Key exclusion criteria (20 listed)
- The subject is already on a significant weight loss trajectory prior to study entry.
- The subject cannot be on an alternative diet plan or strategy (e.g., Weight Watchers, Nutrisystem, Ornish).
- Left ventricular ejection fraction < 50%.
- Severe valvular disease by echocardiogram or dysfunctional prosthetic valve.
- Active pericardial disease (moderate or large pericardial effusion or constrictive pericarditis).
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 |
|---|---|---|
| Ketogenic DietKetogenic diet intervention that is high in fat and low in carbohydrates, causing the body to induce a state of metabolic ketosis, whereby fat is broken down into ketones to provide an energy source for the body. | Other | HFpEF, PH-HFpEF |
Primary outcome
MLHFQ Questionnaire
Time frame: 6 Months
Change in score on the Minnesota Living with Heart Failure Quality of Life (MLHFQ) Questionnaire for the HFpEF cohort. * Max. Score = 105 * Min. Score = 0 * A reduced score means improvement of heart failure symptoms; better outcome
PAH-SYMPACT Questionnaire
Time frame: 6 Months
Change in score on the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire for the PH-HFpEF cohort. * Max. Score = 89 * Min. Score = 0 * A reduced score means improvement of pulmonary hypertension heart failure symptoms; better outcome
36 secondary outcomes
Change in Metabolic Health: Weight
Time frame: 6 Months
Change in Metabolic Health: Glucose
Time frame: 6 Months
Change in Metabolic Health: Insulin
Time frame: 6 Months
Change in Metabolic Health: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 6 Months
Change in Metabolic Health: Albumin
Time frame: 6 Months
Change in Metabolic Health: Bilirubin total
Time frame: 6 Months
Change in Metabolic Health: Alanine Transaminase (ALT)
Time frame: 6 Months
Change in Metabolic Health: Aspartate Aminotransferase (AST)
Time frame: 6 Months
Change in Metabolic Health: Alkaline Phosphatase (ALP)
Time frame: 6 Months
Change in Metabolic Health: High Sensitivity C-Reactive Protein (HS-CRP)
Time frame: 6 Months
Change in Metabolic Health: Triglycerides
Time frame: 6 Months
Change in Metabolic Health: High Density Lipoprotein (HDL)
Time frame: 6 Months
Change in Metabolic Health: Hemoglobin A1c
Time frame: 6 Months
Change in Metabolic Health: Body Mass Index (BMI)
Time frame: 6 Months
Changes in Physical Function: 6 Minute Walk Test (6MWT)
Time frame: 6 Months
Changes in Physical Function: Maximum Oxygen Consumption (VO2max)
Time frame: 6 Months
Changes in Physical Function: Maximum Work
Time frame: 6 Months
Changes in Physical Function: 30 Second Sit-to-Stand test (30s STS)
Time frame: 6 Months
Changes in Physical Function: Leg Press - 1 Repetition Maximum
Time frame: 6 Months
Changes in Physical Function: Chest Press - 1 Repetition Maximum
Time frame: 6 Months
Changes in Physical Function: Leg Extension - 1 Repetition Maximum
Time frame: 6 Months
Cardiac Remodeling: Changes in the Left Ventricle (LV) size
Time frame: 6 Months
Cardiac Remodeling: Changes in the Left Ventricle (LV) thickness
Time frame: 6 Months
Cardiac Remodeling: Changes in the Left Ventricle (LV) mass
Time frame: 6 Months
Cardiac Remodeling: Changes in Left Atrium (LA) size
Time frame: 6 Months
Cardiac Remodeling: Changes in Inferior Vena Cava (IVC) size
Time frame: 6 Months
Cardiac Remodeling: Changes in estimated Right Atrial Pressure (RAP)
Time frame: 6 Months
Cardiac Remodeling: Changes in Right Ventricle Systolic Pressure (RVSP)
Time frame: 6 Months
Changes in the rate of mitral annulus velocity (e')
Time frame: 6 Months
Changes in the ratio of transmitral early peak velocity (E) by pulsed wave Doppler over e' (E/e')
Time frame: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Right Atrial Pressure (RAP)
Time frame: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Pulmonary Artery Pressure (PAP)
Time frame: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Pulmonary Artery Occlusive Pressure (PAOP)
Time frame: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Pulmonary Vascular Resistance (PVR)
Time frame: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Cardiac Output (CO)
Time frame: 6 Months
PH-HFpEF Only Hemodynamics: Changes in Cardiac Index (CI)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 40043832Kodur N, Nguyen C, Tang WHW. Therapeutic Ketosis for Heart Failure: A State-of-the-Art Review. J Card Fail. 2025 Jul;31(7):1051-1061. doi: 10.1016/j.cardfail.2025.01.028. Epub 2025 Mar 3.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with Heart Failure, run by National Jewish Health at 2 sites in United States.
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 18 inclusion and 20 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: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MLHFQ Questionnaire (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 NCT04942548, which also lists 1 linked publication.
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 3 Apr 2024.