## Protocol Section
### Identification Module
**NCT ID:** NCT04063579

**Brief Title:** Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

**Official Title:** Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

#### Organization Study ID Info
**ID:** UW18-022
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-10

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-09-29

**Type:** ACTUAL

#### Start Date
**Date:** 2018-06-01

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2019-08-21
**Type:** ACTUAL
**Study First Submit Date:** 2019-08-16
**Study First Submit QC Date:** 2019-08-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Hong Kong

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction.

**Detailed Description:** Despite the increasing prevalence and poor prognosis of HFpEF worldwide, it is facing diagnostic challenges due to its non-specific clinical manifestations. Currently, echocardiography serves as the main diagnostic tool, but alternatives are limited to less preferred invasive procedures in most clinical situations.

It is therefore proposed to investigate HFpEF using cardiovascular magnetic resonance imaging (CMR), as an alternative non-invasive diagnostic tool which carries lower risk than invasive procedures.

The study aims to: (1) access the utility of CMR-FT as a new indicator to diagnose diastolic dysfunction by differentiating HFpEF patients from non-HFpEF patient and normal volunteers. (2) Compare accuracy of CMR-FT to CMR tagging and phase contrast imaging.

### Conditions Module

**Conditions:**

- Heart Failure With Preserved Ejection Fraction

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 172

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization

**Label:** Patients with heart failure with preserved ejection fraction

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization

**Label:** Non-heart failure patients

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)

**Label:** Normal Volunteers

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non-heart failure patients

- Patients with heart failure with preserved ejection fraction

**Description:** Imaging, blood tests, LV pressure measurement

**Name:** Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Normal Volunteers

**Description:** Imaging and Blood tests

**Name:** Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers

**Time Frame:** 2 years

#### Secondary Outcomes

**Measure:** Complication rate of cardiac catheterisation

**Time Frame:** 2 years

**Measure:** Unexpected findings by CMR (eg. Cardiac amyloidosis)

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients presenting with symptoms and signs suggestive of HFpEF
* Patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction \<50% or significant coronary artery disease (ie. \>50% narrowing of one or more coronary arteries)
* Volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history

Exclusion Criteria:

* Patients suspected to have HFpEF but echocardiography and/or invasive pressure measurements do not confirm diagnosis of HFpEF.
* Significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated.
* Contraindication to CMR study
* Estimated glomerular filtration rate \<30 ml/min/1.73 m2
* More than moderate valvular disease
* Severe pulmonary disease (ie. FEV1 \<- 50% predicted)
* Cardiomyopathy
* Constrictive pericarditis

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** The University of Hong Kong

### References Module

#### References

**Citation:** Ng MY, Kwan CT, Yap PM, Fung SY, Tang HS, Tse WWV, Kwan CNF, Chow YHP, Yiu NC, Lee YP, Fong AHT, Hwang S, Fong ZFW, Ren QW, Wu MZ, Wan EYF, Lee KCK, Leung CY, Li A, Montero D, Vardhanabhuti V, Hai J, Siu CW, Tse HF, Pennell DJ, Mohiaddin R, Senior R, Yiu KH. Diagnostic accuracy of cardiovascular magnetic resonance strain analysis and atrial size to identify heart failure with preserved ejection fraction. Eur Heart J Open. 2023 Mar 7;3(2):oead021. doi: 10.1093/ehjopen/oead021. eCollection 2023 Mar.

**PMID:** 36992915

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Ancestors

- ID: D000045283

- Term: Natriuretic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21935

- Name: Natriuretic Peptide, Brain

- Relevance: HIGH

- As Found: Tiragolumab

### Intervention Browse Module - Meshes

- ID: D000020097

- Term: Natriuretic Peptide, Brain

### Misc Info Module

- Version Holder: 2024-05-24
